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Scope

Project

Scope 

This project team will create a White Paper with recommendations for Adverse Event Collection Instructions, with a focus on Phase 2-4 clinical trials. This project will build upon a paper that outlines results from a survey on current practices, indicating variation that can likely be reduced. Recommendations will be based on the desired end-in-mind, and may or may not be consistent with current practices.



Project LeadsEmails

Aimee

Basile (Surface Oncology)

Basile, Coherus Biosciences

abasile@coherus

abasile@surfaceoncology

.com

Mary Nilsson

(

, Eli Lilly

)Katie Warren (

Nicola Newton, PHUSE Project Assistant

)

katie@phuse Objectives & DeliverablesTimelinesAE Relatedness blogQ42021 White Paper Q22022


Status
colourBlue
titleCurrent Status

Q12022Currently working on draft White Paper 

Q1 2024

  • The AE collection white paper went out for public review – comments due 14 February.   


Published DeliverablesDate

Adverse Event Collection & Treatment Emergent Collection: Version 1.0 

27-Aug-2020Project MembersOrganisationAlec VardyJazz PharmaAndrea RauchBoehringer IngelheimCathy BezekAstellasElisa YoungSouthern Star ResearchJeannine HughesBoehringer IngelheimJun LiSanofiKathy TaylorUnitherKim MusgraveAmgenKit HowardCDISCLaura GoebelJanssen Research & DevelopmentPatrick HannonMMSPranab MitraIndustryRobin WhiteEli LillyTatiana RobersonUnither


Objectives & DeliverablesTimelines
Publish White PaperQ2 2024
William PaloAbbVie